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Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER-positive breast cancer

AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been recommended for approval in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or .

United kingdomAstrazeneca truqapDaiichi sankyoCancer research technologyCommittee for medicinal products human useWorld health organizationInvestor relations teamNational comprehensive cancer networkEuropean medicines agencyInstitute of cancer researchMerck co incEuropean unionNational cancer instituteEnd results programMedicinal productsHuman use

TRUQAP™ (capivasertib) plus fulvestrant approved in the US for patients with advanced HR-positive breast cancer

TRUQAP™ (capivasertib) plus fulvestrant approved in the US for patients with advanced HR-positive breast cancer
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United kingdomUnited statesBrendan mcevoyDaiichi sankyoDave fredricksonKomal jhaveriJillian gonzalesMemorial sloan kettering cancer centerCancer research technologyNational comprehensive cancer networkInstitute of cancer researchEuropean unionEnd results programMerck co incAmerican cancer societyDrug administration

Datopotamab deruxtecan significantly extended progression-free survival vs chemotherapy in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial

AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan reduced the risk of disease progression or death by 37%, providing a 2-month median PFS benefit, and was well tolerated in post-endocrine.

United statesUnited kingdomDaiichi sankyoEnd results programEuropean society for medical oncologySapporo medical universityMerck co incNational cancer institutePresidential symposiumEuropean societyMedical oncologyNorth americaSouth americaRare diseasesCancer statisticsMortality worldwide

Datopotamab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial

First Phase III results in breast cancer for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan Plans for global regulatory submissions underway .

United kingdomUnited statesKen takeshitaDaiichi sankyoSusan galbraithMerck co incEnd results programSapporo medical universityNational cancer instituteExecutive vice presidentGlobal headNorth americaSouth americaRare diseasesCancer statisticsMortality worldwide

Capivasertib in combination with FASLODEX® (fulvestrant) granted Priority Review in the US for patients with advanced HR-positive breast cancer

Decision based on CAPItello-291 Phase III trial results which showed the combination reduced the risk of disease progression or death by 40% vs. FASLODEX alone Potential first-in-class AKT. | June 12, 2023

United kingdomUnited statesSan antonioDaiichi sankyoSusan galbraithAmerican cancer societyDrug administrationCancer research technologyNational cancer instituteMerck co incEnd results programInstitute of cancer researchNational comprehensive cancer networkNew drug applicationPriority reviewPrescription drug user fee act